Prescription medications are effective remedies for many patients when taken according to the respective medical regimen proposed by medical practitioners as well as when taken prior to exposure to high temperatures and/or before expiry of the drug. If not followed, the latter may lead to significant undesirable effects on the subject.
It may be desirable to monitor strict adherence to a given medical regimen in order to, for example, enable effective clinical studies, reduce negative impact on patients, and reduce negative impacts on the healthcare system in general (e.g. hospitalization numbers, admission to nursing homes etc.).
It may further be desirable to simplify the task of the subject when taking such medications. For example, it is desirable that the dosage form itself be capable of communicating to the subject whether it is safe to ingest a given drug (e.g. whether it has been exposed to high temperatures, high enough to degrade one or more compounds in the drug, or whether the expiry date of the drug has been reached/passed, etc.). The latter ensures that a subject not having access to the box of the medicament (e.g. miss-placed) or having sight problems not allowing to read the print on the box to still know whether safe or not to ingest directly by information provided by the dosage form article itself.
It may be further desirable to assist a subject in knowing when a certain medication should be taken. The latter is particularly true for subjects who need to take several combination of medications and all at different intervals.
It may also be desirable to assist a subject in knowing whether a certain medicament is running out and provide an alert to the subject that a new prescription should be requested to continue the cure without the risk of interruption.
Some attempts have been made to address some or part of the above desires, some technologies appearing more successful than others.
For example, in-body devices having deployable antennas have been developed to provide a signal upon contact with a target physiological site, such as described in WO2008/112578. However, such devices have problems of subject acceptance (when antennas are adhered to the outer surface of the dosage form) as well as impacting swallowing of the device and further may lead to drug/signal incompatibilities, added to this is that such devices still do not enable identification of the drug status nor enable addressing some of the other above identified desires.
Other devices, such as those described in WO2010/107980, provide alternative passive signaling means on the outer surface of medication capsules. Again, this leads to subject acceptance issues, swallowability, as well as premature release and activation of the signaling means.
Other devices, such as those described in US2008/0175898A1 provide for signaling means positioned on or integrally with an upper capsule portion, and a drug stored within a lower capsule portion. This configuration has the disadvantage of limiting flexibility in signaling means placement and filling as well as manufacturing complexity (when the latter is positioned integrally with the upper capsule portion) and subject acceptance issues, swallowability, as well as premature release and activation of the signaling means (when the latter is positioned on the capsule). Moreover, a portion of the signaling means may be exposed to a compartment storing the drug or a volume external to the dosage form. The latter may result in drug contamination as well as signal interference depending on the drug and physical state of the drug (particularly when the signaling means is exposed to the drug) as well as premature triggering of the signaling means, increased risk of damage during handling, and swallowing issues (particularly when a portion of the signaling means is exposed to the volume external to the dosage form).
Therefore there still remains a need to overcome the problems of the prior art and achieve the above identified desires via novel dosage form articles and methods.